XEROBURN BURN GEL- lidocaine hydrochloride gel

XeroBurn Burn Gel by

Drug Labeling and Warnings

XeroBurn Burn Gel by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine hydrochloride 2%

PURPOSE

Analgesic

INDICATIONS & USAGE

■ For the temporary relief of pain associated with ■ minor burns ■ sunburn

■ Provides cooling pain relief

WARNINGS

For External Use Only

Do not use

■ on wounds or damaged skin

■ in large quantities, particularly over raw surfaces or blistered areas

When using this product

■ avoid contact with the eyes

■ do not bandage tightly

Stop use and ask a doctor if

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

■ Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

■ Children under 2 years of age: Consult a doctor

INACTIVE INGREDIENT

AACP, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylene glycol, Propylparaben, Purified water, Tea tree leaf oil, Triethanolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XEROBURN BURN GEL 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
METHYLPARABEN (UNII: A2I8C7HI9T)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
GLYCERIN (UNII: PDC6A3C0OX)
IMIDUREA (UNII: M629807ATL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-129-01	6 in 1 BOX	09/07/2017
1		3.5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67777-129-00	25 in 1 BOX	09/07/2017
2		3.5 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 67777-129-02	1728 in 1 CASE	09/07/2017
3		3.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/07/2017

Labeler - Dynarex Corporation (008124539)